Kornimate/medical-research-clean huggingface dataset:
a multicenter, double-blind, randomized, placebo-controlled, 12-week, dose-range-finding trial of ykp10811 capsules administered once daily to subjects with chronic idiopathic constipation

Conditions: Chronic Idiopathic Constipation

Summary: this will be a multi-center, randomized, double-blind, placebo-controlled study of ykp10811 capsules in patients with chronic idiopathic constipation. following a 2-week baseline period, approximately 320 eligible patients with \<3 complete spontaneous bowel movements (csbm) and ≤ 5 sbms per week will be randomly assigned equally to receive one of the following oral treatments; placebo or ykp10811 capsules once daily for 12 weeks followed by a 2 week follow-up period. the objectives of this study are: * to assess the efficacy of ykp10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation. * to determine the safety and tolerability of ykp10811 once daily in subjects with chronic idiopathic constipation.


Eligibility criteria:
inclusion criteria: * patients who meet modified rome ii criteria for chronic constipation. * patients who are male or female, 18 to 65 years of age inclusive. * at visit 3, patients must have \< 3 csbms per week and ≤ 5 sbms per week during the 2-week baseline period. exclusion criteria: * patients who meet rome ii criteria for irritable bowel syndrome (ibs-c). * patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery. * patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (gfr of \< 55ml/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases. * patients with a history of inflammatory bowel disease. * patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening. * patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study. * patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, stevens-johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine.
an observational study of herceptin (trastuzumab) in patients with her2-positive advanced gastric cancer

Conditions: Gastric Cancer

Summary: this observational, multicenter study will assess the efficacy and safety of herceptin (trastuzumab) in routine clinical practice in patients with her2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. data from patients will be collected for approximately 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (gej) with locally advanced and/or metastatic disease * her2-positive tumor * patients who are eligible for treatment with herceptin according to the judgment of the physician exclusion criteria: * unwilling or unable to sign informed consent form * any contraindications, interactions and incompatibilities to herceptin
nordic adjuvant ifn melanoma trial

Conditions: Melanoma; Adjuvant Therapy

Summary: the aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. patients are randomly assigned to either observation only or interferon treatment for 2 different durations. the outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

this is an open multicenter, prospective randomised phase iii trial evaluating the efficacy of two different schedules of interferon-alpha2b (ifn-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (t4n0m0/txn1-2m0). the patients have been operated for either a thick primary melanoma (\> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases. the study consists of a control arm (a) and two treatment arms, b and c. the outcome in arms b and c with adjuvant treatment with ifn-alpha2b will be compared to the outcome of arm a in which the patients will only be observed after the surgery. the primary endpoint is overall survival. secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.

Eligibility criteria:
inclusion criteria: * t4 n0 m0 - thick primary melanoma: \> 4.0 mm breslow depth, without lymph node involvement, or * tx n1-2 m0 primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or * tx n1-2 m0 recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy. * ecog performance status of 0-1 * no active medical or psychiatric disorder requiring therapy that would prevent completion of protocol * written informed consent exclusion criteria: * patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma * patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease * patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy * female patients who are pregnant or lactating

Keywords: randomized phase iii trial adjuvant therapy interferon melanoma
pk study on ready-to-use injection (vsli-rtu) 1 vial & 3 vial formulation marqibo® in hematological malignant patients

Conditions: Hematologic Diseases

Summary: this is a phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (chop) regimen or rituximab-chop (r-chop) regimen.

eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (cohorts a or b) in which the marqibo formulation and the 1-vial vsli-rtu formulation of vincristine are administered in a 2-way crossover design over 2 treatment cycles (21 days each): * cohort a: marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during cycle 1, and vsli-rtu formulation given at 2.25 mg/m2 with no dose cap during cycle 2. * cohort b: vsli-rtu formulation given at a dose of 2.25 mg/m2 with no dose cap during cycle 1 and marqibo formulation given at 2.25 mg/m2 with no dose cap during cycle 2. both formulations of vincristine sulfate liposome injection will be administered via a 60 (±10) minute iv infusion. blood samples for pk evaluation will be drawn at the following time points: immediately before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion (eoi), and 3, 8, 15, 24, 48, 72, and 96 hours post-eoi. in addition to marqibo or vsli-rtu, all patients will receive standard doses (per institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and rituximab if patient is on the r-chop regimen), on day 1 and prednisone (or prednisolone if consistent with institutional or regional guidelines) on days 2 to 5.

Eligibility criteria:
key inclusion criteria: * patient has a hematological malignancy and is eligible to receive chop or r-chop regimen. * patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment: * patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment. key exclusion criteria: * patient has severe neurologic disorders (grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy. * patient has a history of persistent active neurologic disorders including the demyelinating form of charcot-marie-tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions. * patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study. * patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation. * patient has severe, active and uncontrolled hepatic disease or dysfunction.

Keywords: hematology hematological malignancy chop r-chop
evaluation of changes to skin microbiome with tape-stripped wounds

Conditions: Healthy Volunteers

Summary: this single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with fitzpatrick skin types i - iii. microbiome and skin physiology assessments will be completed.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 to 55 years of age. 2. fitzpatrick skin types i to iii. 3. must be able to comprehend and follow the requirements of the study 4. avoid excessive sun exposure 5. willing to refrain from topical product use on the back for the duration of the study. 6. subjects must agree not to immerse their bandages in water for the duration of the study. 7. male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control exclusion criteria: 1. excessively hairy back, acne, scars and pigmentation or nevi t 2. . pregnant or lactating, or planning on becoming pregnant; 3. . known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes; 4. . other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results 5. participation in any other clinical study within 30 days of visit 1; 6. . subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections 7. subjects who report using prescription or otc medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.) 8. subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process 9. individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation 10. . subjects with a known history of keloid or hypertrophic scar formation; 11. subjects diagnosed with any blood clotting disorder; 12. hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 subjects taking oral vitamin a derivatives such as accutane, isotretinon, or using retinoic acid in the past 1 year or using topical vitamin a derivatives in the 3 weeks prior to study start; 14. subjects with clinically infected skin lesions; 15. subjects with cracked or excoriated skin, or other skin problems. 16. diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. subjects with friable skin, at the discretion of the investigator;

Keywords: microflora microbiome skin physiology fitzpatrick skin types i-iii tape-stripped wounds
safety, tolerability and pharmacokinetics of agn-190168 in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: this is a safety, tolerability and pharmacokinetics study of agn-190168 in subjects with acne vulgaris.


Eligibility criteria:
inclusion criteria: * diagnosis of acne vulgaris on the face * no tobacco use for the past 30 days, and willing to refrain from nicotine use during the study * willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study * if male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits * females of childbearing potential must use a reliable method of contraception exclusion criteria: * use of phototherapy devices (eg, clearlight™) and adhesive cleansing strips (eg, ponds® and biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week * use of topical anti-inflammatory drugs, salicylic acid (eg, clearasil® and clean \& clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks * ability to abstain from caffeine-containing products on the dates instructed
alendronate for osteonecrosis in adults with sickle cell disease

Conditions: Sickle Cell Disease; Sickle Cell Anemia; Osteonecrosis; Ischemic Necrosis; Avascular Necrosis

Summary: a prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis

the investigators hypothesize that adults with sickle cell disease (scd) and osteonecrosis of the femoral (hip) and/or humeral (shoulder) heads will tolerate oral alendronate 70 mg administered once a week x 24 weeks (6 months). in addition to collecting safety and tolerability data on alendronate in study participants, the investigators will also measure the preliminary efficacy of alendronate using changes in the adult sickle cell quality of life measurement system (ascq-me) pain impact scores from baseline to 3-months and 6-months after alendronate initiation. serum and urine specimen will also be collected to assess changes in bone biomarkers at baseline, 3-months, and 6-months. the investigators plan to recruit 24 adults with scd from the university of california davis medical center to this single-arm, open label, interventional study. the investigators anticipate enrolling 1-2 participants per month between sep 2024- dec 2025. the study endpoints are summarized below: * to determine the recruitment and retention rates of adults with scd and osteonecrosis enrolled in this prospective, single-arm, open label alendronate interventional study * to measure the safety, tolerability, and preliminary efficacy of oral alendronate in adults with scd-related osteonecrosis over a 6-month treatment duration * to measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points: baseline, 3-months, and 6-months after initiation of alendronate the investigators' goal is to complete primary data analysis by may 2026.

Eligibility criteria:
inclusion criteria: * age 18-80 years with scd (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography) * ability to provide written informed consent * ability to lay on a dual-energy x-ray absorptiometry (dxa) scanner * negative urine pregnancy test for anyone of childbearing potential at study entry exclusion criteria: * pregnant women * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * prisoners * hospitalizations (for any cause) within 2 weeks of study entry

Keywords: sickle cell disease sickle cell anemia osteonecrosis of the femoral head hip osteonecrosis ischemic necrosis of the femur avascular necrosis of the femur
efficacy of endoscopic subureteral injection for vesicoureteral reflux in adults with decreased bladder compliance

Conditions: Vesicoureteral Reflux

Summary: endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. some recent studies suggest that esi can be also a primary treatment option for vur in adults. however, the experience with esi in adults who have vur associated with decreased bladder compliance is limited. we evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.


Eligibility criteria:
inclusion criteria: * who is aged 18 and greater * who underwent endoscopic subureteral injection for vesicoureteral reflux exclusion criteria: * medical records of whom is not evaluabe

Keywords: vesicoureteral reflux low compliant bladder
effect of combined neck strength exerciser plus physiotherapy to treatment chronic neck pain

Conditions: Cervicalgia

Summary: 1. chronic neck pain is common in general population. * high health care source expenditure * multiple therapeutic approaches available with limited evidence * previous studies showed active strengthening exercise improved pain (vas) and functional performance (ndi) * muscle strengthening exercise with biofeedback technique showed more long-lasting effect in patients with chronic neck pain 2. the investigators hypothesize that daily use of the neck strength exerciser (nse), combined biofeedback technique with muscle strengthening exercise posture adjustment, in addition to traditional physiotherapy, could have more long-lasting and prominent effect on pain and functional improvement in patients with chronic neck pain.

1. a randomized single-blinded trial to compare the effect of combined home-based nse with physiotherapy could be more effective to treat people with chronic neck pain * the nse is a simple equipment that is easy to learn and safe to apply as home-based program * the nse will apply to the patients in the nse group for 6 weeks, and we will compare the target variables to see if it brings better improvement by correction of maladaptive habitual posture and daily postural muscle exercise

Eligibility criteria:
inclusion criteria: * adult, ≧20 yr. * constantly or frequently occurring neck pain for more than 3 months in the last 1 year. * motivated and willing to participate in rehabilitation therapy * sign written informed consent. exclusion criteria: * neck or shoulder surgery. * clinical evidence of cervical radiculopathy or myelopathy. * history of disk disease, degenerative joint disease, fracture, or dislocation in the cervical vertebrae. * severe pathological change in the cervical vertebrae, including inflammatory rheumatic disease and tumor. * history of poor diet, hypothyroidism, or other severe systemic disorders. * cognitive deficit and severe psychiatric illness.

Keywords: chronic neck pain neck strength exerciser biofeedback physiotherapy strengthening exercise randomized trials
cognitive therapy in reducing depression in patients with cancer

Conditions: Depression

Summary: the purpose of this study is to learn about treatment of depression in people who have any type of cancer. cognitive therapy (ct) helps improve depressive symptoms by targeting patient's thoughts and behaviors. people who are depressed tend to have more negative or pessimistic thoughts. ct helps people evaluate the accuracy of their thoughts. by encouraging patients to develop more balanced views, symptoms of depression begin to improve

primary objectives: i. determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression. ii. test for the covariation between reduction in depressive symptoms and improvements in quality of life. outline: patients undergo cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions. after completion of study treatment, patients are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * prior diagnosis of invasive cancer, any site, any stage, any time since diagnosis; history of non malignant (basal cell) or low malignant potential (e.g., in situ cervix) cancers do not meet this criterion * diagnosis of major depressive disorder (mdd), according to diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria (american psychiatric association, 2000) * able and willing to give informed consent exclusion criteria: * history of bipolar affective disorder or psychosis * current axis i disorder (e.g. obsessive-compulsive disorder, specific phobia) other than mdd if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered * history of substance dependence in the past six months * subnormal intellectual potential (intelligence quotient \[iq\] below 80) * current suicide risk sufficient to preclude treatment on an outpatient basis * progressive neurological or related conditions/diagnoses * non-ambulatory * life expectancy less than 60 days

Keywords: depression
physiological, microbiological and metabolomic effects of fruit products

Conditions: Constipation - Functional

Summary: this study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.


Eligibility criteria:
inclusion criteria: 1. men and women aged 18-65 years. 2. individuals meeting the rome iv criteria for functional constipation, in addition to having \<7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as type 1 \& 2 of the bristol stool form scale). 3. individuals who are willing to consume fruit products for 4 weeks. 4. individuals who consume \<30g of fibre per day 5. individuals with a bmi of 18.5-29.99 kg/m2. 6. individuals able to give informed consent. exclusion criteria: 1. females who report to be pregnant or lactating. 2. regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week). 3. allergy, intolerance or dislike of the fruit products used in this intervention. 4. sulphite allergy or sensitivity. 5. ongoing alcohol, drug or medication abuse. 6. major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous gi surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy. 7. medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them. 8. frequent use of rescue laxatives.

Keywords: constipation